Acceptability of multiple coated mini-tablets in comparison to syrup in infants and toddlers: a randomised controlled study.

OBJECTIVES: Drug treatment of children is often limited to liquid formulations or manipulation of adult solid oral dosage forms because of the lack of age-appropriate formulations, concerns around particle aspiration and paediatric acceptability. Recent research revealed that the administration of mini-tablets has substantial advantages in improving dose accuracy and avoiding issues related to drug stability, storage conditions, potentially toxic excipients and taste masking (especially effective when the mini-tablets are coated). Most trials were performed with single and multiple uncoated mini-tablets. This study here aimed to investigate young children's acceptability and swallowability of multiple coated placebo mini-tablets compared with glucose syrup. DESIGN: This clinical trial was conducted as a single-centre randomised cross-over study. SETTING: Prospective cross-over study performed at the Children's University Hospital Düsseldorf. PATIENTS: This study was conducted on 50 children in five age groups from 1 to <6 years. INTERVENTIONS: An age-adapted amount of 16-28 mini-tablets and 3-6 mL syrup was administered in randomised order. MAIN OUTCOME MEASURES: Acceptability and swallowability of multiple coated mini-tablets and syrup. RESULTS: In all age groups, administration of multiple coated mini-tablets and syrup showed good acceptability (mini-tablets 80%-100%, syrup 90%-100%) and swallowability (mini-tablets 30%-70%, syrup 20%-80%) without any clinically meaningful difference. This is consistent with results from large studies with uncoated mini-tablets. CONCLUSION: Multiple coated mini-tablets are a suitable age-appropriate alternative to liquid formulations in the paediatric population. No safety concerns with the use of coated mini-tablets were observed in the study. TRIAL REGISTRATION NUMBER: DRKS00010395.